Peripheral arterial disease (PAD) is almost invariably associated with a generalized atherosclerotic involvement of the arterial tree and endothelial dysfunction. Previous short term studies showed improvement of vascular reactivity and walking capacity in PAD patients by measures aimed at restoring Nitric Oxide (NO) production. NO is also known to prevent the progression of atherosclerosis. We wished to assess whether the prolonged administration of a NO-donating agent (NCX 4016) improves the functional capacity of PAD patients and affects the progression of atherosclerosis as assessed by carotid intima-media thickness (IMT).

Four hundred forty two patients with stable intermittent claudication were enrolled in a prospective, double blind, placebo-controlled study and randomized to either NCX 4016 800mg bid or its placebo for 6 months. The primary study outcome was the absolute claudication distance (ACD) on a constant treadmill test (10% incline, 3km/hr); main secondary end-point was the change of the mean far-wall right common carotid artery IMT.

All other concomitant treatments were kept constant as much as possible during the study period.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01256775

Locations

Italy

Ospedale di Perugia

Perugia, Italy, 06126

Sponsors and Collaborators

NicOx Research Institute S.r.l.

Investigators

Principal Investigator:

Paolo Gresele, M.D., Ph.D.

University of Perugia, Italy

More Information

No publications provided

Responsible Party:

NicOx Research Institute, Paolo Gresele, University of Perugia - Italy